Identity
- Trade Name
- MODEL LI30U SOFLEX(TM) UV-ABSORB. INTRAOCULAR LENS FDA PMA
- Generic Name
- intraocular lens FDA PMA
Identifiers
- PMA Number
- P910061 FDA PMA
- FDA Product Code
- HQL FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Legislation / Framework
- 21 CFR Part 886.3600 FDA PMA
- Regulation Number
- 886.3600 FDA PMA
- Advisory Committee
- Ophthalmic FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The LI61AO Lens is an intraocular lens, a prosthetic device implanted within the eye to replace the natural lens following cataract surgery or to correct refractive errors. It is designed to restore visual function by focusing light onto the retina, ensuring clear vision for the patient.
This lens is supplied sterile and intended for single-use in ophthalmic surgical procedures. It is classified as a Class III medical device under FDA regulations and has received Premarket Approval (PMA) under the designation P910061. The device is packaged for sterile use and must be handled according to aseptic techniques to maintain integrity before implantation.
Frequently asked questions
What is the LI61AO Lens used for in ophthalmic procedures?
The LI61AO Lens is an intraocular lens designed to replace the natural lens after cataract surgery or to correct refractive errors. It is implanted within the eye to restore visual function by focusing light onto the retina, ensuring clear vision for patients. This prosthetic device is specifically intended for use in ophthalmic surgical procedures to improve vision post-surgery.
Is the LI61AO Lens intended for single-use or can it be reused?
The LI61AO Lens is explicitly supplied sterile and intended for **single-use only** in ophthalmic surgical procedures. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility and patient safety. Proper aseptic techniques must be followed to maintain its integrity before implantation.
How is the LI61AO Lens packaged, and what storage precautions should be taken?
The LI61AO Lens is packaged sterile for surgical use, meaning it is pre-sterilized and sealed to prevent contamination. Since it is single-use, it should be stored in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Always check the expiration date and ensure the packaging remains intact before use to guarantee sterility.
What regulatory approval does the LI61AO Lens hold, and how was it classified?
The LI61AO Lens holds **Premarket Approval (PMA)** from the FDA under the designation **P910061**, indicating it has undergone rigorous review for safety and effectiveness. It is classified as a **Class III medical device**, which is the highest risk category under FDA regulations, reserved for devices that support or sustain human life or are of substantial importance in preventing impairment of human health.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P910061 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bausch and Lomb
- FDA Applicant
- Bausch & Lomb
Sources (1)
- FDA PMA P910061 24 fields · synced Sep 18, 2026